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EU states add pressure on Pfizer to cut unneeded vaccine supplies

An elderly couple wearing protective face masks against COVID-19 walks past the Pfizer Inc headquarters on Dec 9, 2020 in New York City. (ANGELA WEISS / AFP)

GENEVA / BRUSSELS / MEXICO CITY / BERLIN / THE HAGUE / ROME / OTTAWA / ADDIS ABABA – European Union governments are intensifying pressure on Pfizer and other COVID-19 vaccine makers to renegotiate contracts, warning millions of shots that are no longer needed could go to waste, according to EU officials and a document.

During the most acute phase of the pandemic, the European Commission and EU governments agreed to buy huge volumes of vaccines, mostly from Pfizer and its partner BioNTech, amid fears of insufficient supplies.

But with the pandemic abating in Europe and amid a marked slowdown in vaccinations, many countries are now urging tweaks to contracts to reduce supplies and consequently cut their spending on vaccines.

The matter was discussed on Tuesday at a meeting of EU health ministers in Luxembourg, although the Commission – the EU executive – remained cautious on what could be achieved.

Poland, the leading country in this attempt to revise contracts, has more than 30 million COVID-19 vaccines in stock and would need to buy another 70 million under existing agreements, a Polish diplomat told Reuters, urging changes to avoid waste.

Poland has a population of about 38 million, with about 60 percent fully vaccinated, not including boosters – compared with more than 70 percent in the EU as a whole.

In a letter sent to the Commission earlier in June, and seen by Reuters, Polish Health Minister Adam Niedzielski together with counterparts from Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania and Romania called for a "reduction of the amounts" of vaccines being ordered.

Pfizer and Moderna, which is another top supplier of COVID-19 vaccines to the EU, have agreed to postpone some deliveries.

However, the ministers said in their joint letter, referring only to tweaks agreed with Pfizer, that they were "an insufficient solution and only delay the problem".

EU Health Commissioner Stella Kyriakides told Tuesday's public session that the Commission would work to further extend deliveries beyond this year.

She warned that excess doses could be needed in the future, and noted: "Contracts must be honoured", adding the EU "cannot unilaterally change the terms of the contracts".

Tunisians wait for their turn to receive a COVID-19 veccine at an inoculation center in Ariana governorate near the capital Tunis on Aug 8, 2021. (FETHI BELAID / AFP)

Africa

The number of confirmed COVID-19 cases in Africa reached 11,700,191 as of Tuesday evening, the Africa Centers for Disease Control and Prevention said.

The specialized healthcare agency of the African Union said the COVID-19 death toll across the continent stands at 253,607 and some 11,063,181 patients have recovered from the disease so far.

South Africa, Morocco, Tunisia and Libya are among the countries with the most cases on the continent, said the Africa CDC.

South Africa has recorded the most COVID-19 cases in Africa with 3,979,126 cases, followed by the northern African country of Morocco with 1,176,165 cases, it said.

In terms of regional caseload, southern Africa is the most affected region in Africa, followed by the northern and eastern parts of the continent, while central Africa is the least affected, said the Africa CDC.

Photo taken on July 15, 2020 shows the exterior view of the World Trade Organization (WTO) headquarters in Geneva, Switzerland. (PHOTO / XINHUA)

Britain

Britain, one of the main opponents to waiving intellectual property rights for COVID-19 vaccines, praised a draft agreement and expressed hope a deal would be reached at the World Trade Organization this week.

India, South Africa and other developing countries have sought a waiver of IP rights for vaccines, treatments and diagnostics for over a year, but faced opposition from countries with major pharmaceutical producers, such as the United Kingdom and Switzerland.

A provisional deal between major parties – India, South Africa, the United States and the European Union – emerged in May, but trade sources say Britain and Switzerland have continued to express concerns that it goes too far.

"We've got to a text which I think is very good. I think some of the concerns early on have been alleviated," Anne-Marie Trevelyan told Reuters on the sidelines of a four-day WTO ministerial meeting in Geneva, without being more specific.

"We are in the final throes of one word here, one word there. I am hopeful that we will land something that is good," she added.

A source closely following the talks said the British position was now "more conciliatory" but other challenges remained, including which products the waiver would apply to and which countries might be able to benefit from a waiver and produce vaccines locally.

An Air Canada plane at Montreal-Pierre Elliott Trudeau International Airport on Oct 3 2021. (DANIEL SLIM / AFP)

Canada

Canada will suspend its requirement to be vaccinated against COVID-19 for domestic travel and to work in the civil service from June 20, the federal government said on Tuesday, after provinces lifted most health restrictions in recent months.

The requirement was suspended due to Canada's high vaccination rate and a decrease in coronavirus infections, according to a government statement. Some 32 million, or nearly 90 percent, of eligible Canadians are vaccinated.

The mandate was also suspended for people departing from Canada. It may be reinstated later, especially in the case of a surge of a new variant.

"While the suspension of vaccine mandates reflects an improved public health situation in Canada, the COVID-19 virus continues to evolve and circulate in Canada and globally," Health Minister Jean-Yves Duclos said in a statement.

International travelers coming to Canada would still be required to show proof of vaccination.

The mandates for domestic travel and the civil service have been in place since Oct 30, 2021, about a month after Liberal Prime Minister Justin Trudeau won a third election in part by promising to take a hard line on vaccinations.

Spurred by the mandate, 95 percent of public employees confirmed they had received two shots of a vaccine.

Some unvaccinated federal workers, who were put on unpaid leave due to the mandate, would now be allowed to resume normal duties, said Treasury Board President Mona Fortier.

This summer, with infections declining, most provinces have dropped even their masking requirements, and the Trudeau government has come under increasing pressure from the opposition and industry to relax mandates more broadly.

In this file photo taken on Nov 30, 2021 a doctor vaccinates a patient against COVID-19 at a vaccination center in Sonthofen, southern Germany. (CHRISTOF STACHE / AFP)

Germany

Germany recorded more than 100,000 new COVID-19 infections within one day for the first time since April, the Robert Koch Institute (RKI) for infectious diseases said on Tuesday.

Germany's national seven-day rate per 100,000 inhabitants more than doubled during the last week to around 447, according to the RKI. In March, the incidence peaked at around 1,700 as a result of the Omicron wave.

"A summer wave was to be expected," said Minister of Health Karl Lauterbach on Twitter Tuesday. "Voluntary wearing of masks indoors and a fourth vaccination are the best antidotes."

Most COVID-19 restrictions in Germany have been relaxed. It is one of the last countries in the European Union to drop restrictions for entering from an EU member state for the summer months.

This comes at a time when the two more contagious Omicron subvariants BA.5 and BA.4 are on the rise. Within a week, the share of BA.5 in Germany doubled to 10 percent, according to the RKI's latest weekly report.

A health worker administers a dose of the Johnson & Johnson vaccine (Janssen) against COVID-19, on Aug 5, 2021 at the Ambreck pharmacy, in Milan. (MIGUEL MEDINA / AFP)

Italy

Italy is on the verge of removing its final coronavirus health restrictions, though masks may still be mandatory on public transportation and in hospitals, a top health official said Tuesday.

The comment from Italian Health Undersecretary Andrea Costa came amid a gradual increase in COVID-19 infection rates, though other indicators – hospitalization rates, the number of patients in intensive-care units, and coronavirus-related deaths – remain relatively low.

On Friday, Italy's High Institute of Health reported that during the one-week period ending the day before, the country's COVID-19 infection rate was 222 per 100,000 residents, an increase from 207 per 100,000 residents reported the previous week. The rate had been in decline since April.

In an interview on Radio Capitale, Costa was asked to comment on the possible lifting of the mask mandate after the June 15 expiration of the current rules. Costa said the mask mandate will be lifted as scheduled in cinemas, theaters, and during indoor sporting events. However, masks are likely to remain mandatory on public transportation and in hospitals until September.

The mask mandate will likely be extended "for the most crowded places and those where a little more prudence is needed," Costa said.

Nurses wait for people to come to get AstraZeneca or Pfizer COVID-19 vaccines at a vaccination center in Guadalajara, Jalisco state, Mexico on April 6, 2022. (ULISES RUIZ / AFP)

Mexico

Mexico will begin vaccinating children between 5 and 11 years old against COVID-19 in the coming days, following the completion of six immunization phases, Undersecretary of Prevention and Health Promotion Hugo Lopez-Gatell announced Tuesday.

The official said the process will be carried out by municipalities, with registration starting on Thursday.

"In essence, the policy has been very consistent with what we planned from the beginning," Lopez-Gatell told journalists from the National Palace in Mexico City.

The country began its national vaccination program at the end of 2020 in phases divided into age groups that started with the elderly.

For the upcoming phase, authorities estimate that 15.4 million children between the ages of 5 and 11 will be vaccinated.

People walk past a sign outlining COVID-19 guidelines in the center of Amsterdam, the Netherlands on Dec 18, 2021. (PETER DEJONG / AP)

Netherlands

New COVID-19 infections rose by 64 percent in the Netherlands over the past week, official data show on Tuesday.

In the past seven days, the country reported 15,526 new infections, the National Institute for Public Health and the Environment (RIVM) said.

The significant rise of positive tests was probably due to the spread of Omicron subvariants BA.4 and BA.5, which are "gaining more and more ground in the Netherlands," said the RIVM.

While an increase of new cases was reported in all age groups, infections rose fastest in the Amsterdam-Amstelland, Utrecht and Hollands-Midden regions.

The number of virus particles in sewage water has also been increasing throughout the Netherlands for two weeks, it noted.

Despite the sharp rise of new infections, the number of new hospitalizations of patients with COVID-19 has increased only by 12 percent, it said.

Pfizer

Pfizer Inc said on Tuesday it would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after a study revealed the treatment was not effective in reducing symptoms in that group.

The drug has emergency use authorization for high-risk groups in which it has been effective in reducing hospitalizations and deaths.

The new data, however, showed a 51 percent relative risk reduction in standard-risk groups, which the company said was not statistically significant.

The standard-risk population usually includes people who do not have health conditions that put them at risk of severe disease and who can recover without the drug.

Pfizer said it will include the new data in the company's upcoming application to the US Food and Drug Administration seeking full approval for the drug's use in high-risk groups.

Data from a study in Israel earlier this month showed the drug reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, but was not found to prevent severe illness among younger adults.

This file photo taken on June 4, 2021 shows a vial of the Moderna COVID-19 vaccine at a pharmacy in Paris, France. (STEPHANE DE SAKUTIN / AFP)

United States

Advisers to the US Food and Drug Administration on Tuesday unanimously recommended that the agency authorize Moderna Inc's COVID-19 vaccine for children and teens aged 6 to 17 years of age.

Around 77 million people in the United States have received at least a two-dose course of Moderna's vaccine, which has long been available for people aged 18 and older.

The committee of outside experts is scheduled on Wednesday to consider the Moderna shot for children under 6, and Pfizer and BioNTech's COVID-19 vaccine for children under 5 – and in both cases as young as 6 months.

There is unlikely to be significant immediate demand the Moderna shots for 6- to 17-year olds. The Pfizer/BioNTech vaccine was authorized for children aged 5 to 11 in October, and approval for teenagers preceded that by months.

Yet only around 30 percent of those ages 5 to 11 and 60 percent of 12- to 17-year olds are fully vaccinated in the United States, according to data from the US Centers for Disease Control and Prevention (CDC).

"I'd like to give parents as many choices as possible, and let them make the decisions about this for their children," committee member and UC Berkeley professor Dr. Arthur Reingold said at the meeting.

The FDA – which generally follows the recommendations of its advisers but is not obligated to do so – is likely to authorize the Moderna vaccine for ages 6-17 soon. The CDC also needs to recommend the vaccine's use. A committee of its advisers is scheduled to meet Friday and Saturday.

There have long been concerns that the Moderna vaccine, which is given at a higher dose than the Pfizer/BioNTech shot, may cause types of heart inflammation known as myocarditis and pericarditis at higher rates, primarily in younger males.

Some countries in Europe have limited use of Moderna's vaccine for younger age groups after surveillance suggested it was tied to a higher risk of heart inflammation, and the FDA delayed its review of the shot to assess the myocarditis risk.

US regulators presented data at the meeting on Tuesday suggesting that Moderna's vaccine may have a higher risk of heart inflammation in young men, but said the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.